Filling system and method for syringes with short needles

ABSTRACT

A filling system for syringes utilizing short needles to be filled from a vial having a thick septum is described. The system may be useful in any situation where the septum or vial stopper of a medication container is thicker than the usable length of the needle on the delivery device. Preferably, the syringe is filled just prior to use. The short needle includes an optional limiter which only permits a certain predetermined length of the needle cannula to protrude beyond the limiter a distance which limits penetration of the needle tip into both the skin and a vial stopper. The system and adapter may be useful for needles having a protrusion distance from approximately 0.5 mm to 3 mm, or any needle with a protrusion length shorter that the thickness of a septum to be accessed. Furthermore, a device is provided with shielding capabilities to shield the needle of the device.

REFERENCE TO RELATED APPLICATIONS

This Application is claiming the benefit under 35 U.S.C. 119(e) toProvisional Application Ser. No. 60/661,367, filed Mar. 14, 2005.

FIELD OF THE INVENTION

The present invention relates generally to filling of delivery devicesfor delivering substances such as drugs, vaccines and the like, and morespecifically relates to a drug delivery system and device having aneedle which has a relatively short protrusion length. Morespecifically, the present invention relates to a method and apparatusfor filling an intradermal delivery device using a needle sized forintradermal delivery to fill the syringe.

BACKGROUND OF THE INVENTION

Intradermal injections are used for delivering a variety of substances.Many of these substances have proven to be more effectively absorbedinto or react with the immune response system of the body when injectedintradermally. Recently, clinical trials have shown that hepatitis Bvaccines administered intradermally are more immunogenic if administeredintramuscularly. In addition, substances have been injectedintradermally for diagnostic testing, such as, for example using what isknown in the art as the “Mantoux test” to determine the immunity statusof the animal against tuberculosis and the immediate hypersensitivitystatus of Type I allergic diseases.

An intradermal injection is made by delivering the substance into theepidermis and upper layers of the dermis. Below the dermis layer issubcutaneous tissue (also sometimes referred to as the hypodermis layer)and muscle tissue, in that order. There is considerable variation in theskin thickness both between individuals and within the same individualat different sites of the body. Generally, the outer skin layer,epidermis, has a thickness between 50-200 microns, and the dermis, theinner and thicker layer of the skin, has a thickness between 1.5-3.5 mm.Therefore, a needle cannula that penetrates the skin deeper than about3.0 mm has a potential of passing through the dermis layer of the skinand making the injection into the subcutaneous region, which may resultin an insufficient immune response, especially where the substance to bedelivered intradermally has not been indicated for subcutaneousinjection.

The standard procedure for making an intradermal injection via theMantoux technique is known to be difficult to perform, and thereforedependent upon experience and technique of the healthcare worker. Thisprocedure is recommended to be performed by accessing the vial with theneedle and aspirating the medication into the syringe, stretching theskin, orienting the bevel of short bevel needle cannula (in oneembodiment, a 26G×½″) upwardly and inserting the needle cannula todeliver a volume of 0.5 ml or less of the substance into the skin of ananimal with the needle cannula being inserted into the skin at an anglevarying from around 10-15 degrees relative to the plane of the skin toform a blister or wheal in which the substance is deposited or otherwisecontained. Accordingly, the technique utilized to perform the standardintradermal injection is difficult and requires the attention of atrained nurse or medical doctor; however this method does have theadvantage of allowing the filling of the syringe directly from the vial.FIG. 2 of US Published Application No. 2005-0203459 A1 to Alchas shows aconventional syringe being filled from a multi-dose vial, whichdemonstrates that the length of the needle must be sufficient to fullypenetrate the septum of a vial in order to aspirate the medication.Inserting the needle to a depth greater than about 3.0 mm may results ina failed intradermal injection, as the substance being expelled throughthe cannula will be injected into the subcutaneous tissue of the animal.Further, the standard method is not suitable for self-administration ofintradermal injections. However, this method does have the advantage ofbeing able to use the same needle for penetrating the vial and fillingas is used for performing the injection, allowing the practitioner toselect a fixed needle, which reduces dead space.

For many drug substances, it may be desirable to fill the deliverydevice at the point of, and immediately prior to use. In this situation,the delivery device is normally filled from a multi-dose vial. Amulti-dose vial may be more economical and it enables the user to fillthe delivery device with the specific dose required. The multi-dose vialmay be pre-filled with a liquid substance or with a dry substance. Forexample, it is now conventional to reduce certain drugs to a dry orpowdered form to increase the shelf life of drugs and reduce inventoryspace and pre-fill (or fill at time of use) a syringe with diluent forreconstitution of the dry drug. Multi-dose vials may be sealed with anelastomeric stopper or septum of thickness exceeding 3 mm. Additionally,some vial septums are coated with hard materials like PTFE (e.g. Teflon®PTFE) which could damage the filling needle upon penetration. A needleon the delivery device may be used to pierce the stopper or septum anddraw the drug substance from the vial into the delivery device,typically a syringe. The drug substance may then be administered usingthe delivery device, which is discarded after use, and the unit-dosevial may be stored for further use. One problem with using a shortneedle which is suitable for intradermal injection is that the needleused for injection, when penetrated into certain vials is not longenough to access the medication within the vial.

Vial adapters to aid in penetration of vials have been proposed in thepast. Various designs have been proposed in the past to align the vialto the syringe. One example of such a device is related in U.S. Pat. No.5,356,406 to Shraga. The design of this adapter is such that it providesguidance of the needle to the vial. The vial adapter of '406 requiresthe use of a needle of sufficient length to penetrate the septum of thevial. Another such example of a vial adapter is related in U.S. Pat. No.4,944,736 Holtz. The design of this adapter is such that it providesguidance of the needle to the vial. In addition, the vial adapter of'736 requires the use of a needle of sufficient length to penetrate theseptum of the vial.

Further, with the advent of viral infections that are transferredthrough contact with bodily fluids, it is desirable to enclose orconceal a needle cannula subsequent to administering an injection.Preferably, a delivery device should include a mechanism that is capableof enclosing a needle cannula immediately subsequent to administeringthe injection. If a needle is left uncovered for even a short period oftime after administering an injection, such as, for example, whiletrying to reattach a needle cap, a biohazard exists. Therefore, it maybe desirable to provide an intradermal delivery device with a means forenclosing the needle cannula that is simply designed, easy to use, andreadily available immediately after administering an injection.

The use of intradermal delivery systems is expected to increase. Use ofa “standard” length needle to deliver a drug substance intradermally hasits shortcomings, some of which are identified above. It is not possibleto use a delivery device having a needle length suited for intradermalinjection to aspirate a syringe with drug substance from a standardmulti-use vial. Thus, there are shortcomings in the prior art thatprevent filling an intradermal injection using a “short” length needleand a multi-use vial. As a result, there is a need to pre-fill anintradermal device, or to use a “long” detachable needle for filling thedevice and a “short” detachable needle for the drug administration,resulting in dead space losses. It would be advantageous to have a drugdelivery device capable of accessing substances stored in multi-dosevials and delivering such substances into the intradermal region of theskin without encountering the shortcomings described above.

SUMMARY OF THE INVENTION AND ADVANTAGES

An intradermal injection device with a reservoir within which a drugsubstance may be held is able to be filled from a vial having a thickseptum through the short needle by utilizing the device and method ofone aspect of the invention. In accordance with one embodiment, theneedle assembly of the device to be filled is specifically designed formaking intradermal injections; however the devices and methods of theinvention may be useful in any situation where the septum or vialstopper of a medication container is thicker than the usable length ofthe needle on the delivery device. The needle assembly, in accordancewith one embodiment, includes a penetration limiter which permits acertain predetermined length of the needle cannula to protrude beyondthe limiter a distance which limits penetration of the needle tip intothe intradermal space of the patient's skin. In accordance with oneembodiment, the needle tip extends beyond the skin engaging surface adistance ranging from approximately 0.5 mm to 3 mm. The needle assemblymay be secured to the syringe via a hub portion, which may be integrallyformed in the syringe body or the hub portion may be separate anddetachably secured by a Luer fit or equivalent attachment method. As maybe appreciated from FIG. 3, it is not possible, using a device having astationary limiter at the short lengths required for intradermalinjection, to fill a reservoir from a conventional vial having a septumof a thickness greater than the protrusion of the needle. The distancethe needle protrudes from the limiter is too short to adequatelypenetrate the depth of the septum and access the substance contained inthe vial. Aspects of the present invention allow for access to asubstance contained in a conventional vial by an intradermal needledevice or assembly. Alternatively, it may be desirable to pre-fill thesyringe with a diluent and use the devices and methods having aspects ofthe invention for mixing of diluent and active ingredient. Thus,standard methods for preserving the therapeutic and/or diagnosticsubstances, such as maintaining them in liquid or powder form inconventional vials for future use, may be used with the system of thepresent invention. Furthermore, using the intradermal filling deviceshaving aspects of the present invention, it is possible to useconventional, inexpensive delivery devices such as fixed needle plasticsyringes, in conjunction with the intradermal devices, which reducesdead-space and are often not appropriate for use as fill at time of usedevices.

Aspects of the present invention also support the vial such that it doesnot need to be supported by the free hand during the drawing ofmedicament. Additionally, aspects of the invention are directed toproviding systems and devices for guidance and/or retention of thesyringe to the vial adapter. These same systems may optionally formcomponents of a safety needle shielding system.

Aspects of the present invention provide a fluid transfer system for usein transferring a medical substance from a medication container having aseptum with a pre-determined thickness into a delivery device. Thedelivery device has a reservoir adapted for storing a medical substanceand a needle cannula attached to the delivery device with a lumen influid communication to the reservoir. The needle has a forward tipextending away from the delivery device a pre-selected usable length,wherein the usable length is less than a thickness of a septum of themedication container. The system utilizes an adapter body which includesa container receiving portion with a septum access needle, and alongitudinal projection extending from the adapter body. The projectionincludes an adapter septum having a thickness less than the usablelength of the needle cannula. When the container is inserted into thecontainer receiving portion and the delivery device needle is penetratedthrough the adapter septum, fluid communication is established to thesubstance in the container such that it is allowed to be aspirated intothe reservoir. Optionally, the system further comprises a shield whichis slidably disposed upon the delivery device. The shield has at least atwo positions, a first position exposing the forward tip of the needlecannula and a second position concealing the forward tip of the needlecannula. Optionally, the system further comprises a shield whichincludes at least one slot wherein the slot cooperates with acorresponding feature on the vial adapter protrusion. Optionally, thevial adapter protrusion includes at least one locking finger or tangreceived by the slot in the shield. Optionally, the locking features aredisposed in a helical pattern. In an alternate embodiment of the shield,the shield is slidably disposed upon the delivery device having at leasta first position and a second position, the first position concealingsaid forward tip of said needle cannula and the second position exposingsaid forward tip of said needle cannula. Optionally, in this embodiment,a locking clip is used which is slidably disposed between the shield andthe delivery device. The clip itself has at least two positions. A firstposition of the clip allows proximal movement of the shield with respectto the delivery device. The second position of the clip preventsproximal movement of the shield with respect to the delivery device.Optionally, movement of the shield with respect to the delivery deviceengages the clip and moves the clip into a second position of the clip,thereby preventing proximal movement of the shield with respect to thedelivery device.

Additionally, a method of intradermally injecting a substance isprovided including the steps of providing a vial adapter for use with avial having a septum with a pre-selected thickness, and providing anintradermal injection device having a predetermined usable length ofneedle, inserting the vial into the vial adapter, inserting theintradermal device into the vial adapter, filling the intradermaldevice, removing the intradermal device from the vial adapter, andpressing the intradermal device to the patient's skin such that the skinengaging surface of the limiter encounters the skin and preventspenetration of the needle cannula deeper than about 3 mm; and injectingthe substance under conditions and for a time sufficient to deliver thesubstance into the dermis layer of the skin.

Other aspects of the invention include a delivery device having areservoir within adapted for storing a medical substance. The deviceincludes a needle cannula attached to the delivery device having a lumenin fluid communication to the reservoir and having a forward tipextending away from the delivery device a pre-selected usable length.The device also includes a shield which is slidably disposed upon thedelivery device having at least a first position and a second position.The shield's first position conceals the forward tip of the needlecannula and the second position exposing the forward tip of the needlecannula. The device also includes a locking clip which is slidablydisposed between the shield bore and the delivery device. The clip hasat least a first position and a second position, the clip's firstposition allows proximal movement of the shield with respect to thedelivery device and the clip's second position prevents proximalmovement of the shield with respect to the delivery device. In use, afirst proximal movement of the shield with respect to the deliverydevice into the shield's second position engages the locking clip andmoves the locking clip into the second position of the locking clip,thereby preventing subsequent proximal movement of the shield withrespect to the delivery device. Optionally, the shield includes at leastone slot wherein the slot cooperates on a corresponding feature on amedication vial protrusion, wherein the cooperation allows removableattachment of the delivery device to the container.

BRIEF DESCRIPTION OF THE DRAWINGS

Other advantages of the present invention will be readily appreciated asthe same becomes better understood by reference to the followingdetailed description when considered in connection with the accompanyingdrawings wherein:

FIG. 1 shows an embodiment of an intradermal injection device having anintradermal needle assembly inserted into a vial adapter in accordancewith one aspect of the invention, in perspective view.

FIG. 2 shows a cross-sectional view of the assembly of FIG. 1.

FIG. 3 shows a perspective view of an intradermal injection device asused in the assembly of FIG. 1.

FIG. 4 shows a perspective cross-sectional view of the vial adapter ofthe assembly of FIG. 1.

FIG. 5 shows a perspective cross-sectional view of the assembly of FIG.1, with the plunger in a position to aspirate the medication.

FIG. 6 shows a perspective view of an embodiment of an intradermalinjection device having a detachable intradermal needle assemblyinserted into a vial adapter in accordance with one aspect of theinvention, in perspective view.

FIG. 7 shows a cross-sectional view of the assembly of FIG. 6.

FIG. 8 shows a perspective view of the vial adapter of the assembly ofFIG. 6 with the intradermal needle assembly attached.

FIG. 9 shows a perspective view of the vial adapter of the assembly ofFIG. 6.

FIG. 10 shows an embodiment of an intradermal injection device having ashieldable intradermal needle assembly prior to insertion into a vialadapter in accordance with one aspect of the invention, in perspectiveview.

FIG. 11 shows a partial cross-sectional view of the assembly of FIG. 10.

FIG. 12 shows a partial side cross-sectional view of the assembly ofFIG. 10.

FIG. 13 shows a side view of the assembly of FIG. 10 with the shieldactivated.

FIG. 14 shows a perspective view of the vial adapter of the assembly ofFIG. 10.

FIG. 15 shows an enlarged side cross-sectional view of the assembly ofFIG. 10, with the needle inserted into the vial adapter.

FIG. 16 shows an embodiment of an intradermal injection device having ashieldable intradermal needle assembly inserted into a vial adapter inaccordance with one aspect of the invention, in perspective view.

FIG. 17 shows an enlarged side cross-sectional view of the assembly ofFIG. 16, with the needle inserted into the vial adapter.

FIG. 18 shows an exploded view of the assembly of FIG. 16.

FIG. 19 shows a side cross sectional view of the intradermal deviceassembly of FIG. 16 with the shield in an injection position.

FIG. 20 shows the assembly of FIG. 19 with the shield in position afteractivation.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As used herein, the term “proximal” and derivatives thereof, shall meanthe end of an item or direction closest to the caregiver during use ofthe subject invention. The term “distal” and derivatives thereof, shallmean the end of an item or direction towards a patient during use of thesubject invention. As used herein, the term “septum” and derivativesthereof shall mean any breachable barrier that is intended for sealing afluid conduit or container, including, by way of non-limiting example,vial stoppers, cartridge stoppers, films, elastomeric rubber stoppers,and septum valves. As used herein, the term “drug substance” andderivatives thereof, shall mean any substance that is intended forinjection into a patient, including, by way of non-limiting example,drugs, vaccines, therapeutics, and the like. It will be obvious to aperson of skill in the art, and from the disclosure provided herein,that the subject invention is not limited or otherwise defined by thetype or class of substance administered using the inventive injectiondevice.

FIGS. 1-3 shows an intradermal injection device 1 comprising a syringe14 having a syringe body 16 that defines a reservoir 18 within which adrug substance may be held. A plunger 20 is disposed in the syringe body16. Plunger 20 has a flange 22 at a distal end thereof and a stopper 24at the opposed proximal end thereof. Device 1 has a needle assembly 2secured to a distal end of the syringe body 16. An exemplary needleassembly 2 and intradermal injection device 1 of the type depicted inFIG. 3 is disclosed in U.S. Pat. Nos. 6,494,865; 6,569,143; 6,689,118;6,843,781; 6,569,123; 6,776,776; and US Published Application No.2005-0203459 A1 to Alchas and Alchas et al., the entire contents of eachof which are incorporated by reference herein in their respectiveentireties. The needle assembly 2 is specifically designed for makingintradermal injections. The needle assembly 2 carries a needle cannula 4having a needle tip 6 at a distal end thereof. Alternatively, the needlecannula 4 may be secured directly to the syringe body 16. The needleassembly 2 may also includes a penetration limiter 8 having a hubportion 9 that may be secured to the syringe body 16, and a limiterportion 11 that defines a skin engaging surface 10 at a distal end ofthe limiter 8. The limiter 8, which generally surrounds the proximal endof the needle 4, permits a certain predetermined length of the needlecannula 4, including the needle tip 6, to protrude beyond the skinengaging surface 10 so that the distance between the needle tip 6 andskin engaging surface 10 limits penetration of the needle tip 6 into theintradermal space of the patient's skin. Preferably, the needle tip 6 ofthe needle cannula 4 extends beyond the skin engaging surface 10 adistance ranging from approximately 0.5 mm to 3 mm. The needle cannula 4and skin engaging surface 10 are optionally arranged with respect toeach other in a pre-determined angular relationship that serves toensure a pre-determined angular relationship (e.g. generallyperpendicular) between the needle cannula 4 and the patient's skin; sucha pre-determined angular relationship being preferred when makingintradermal injections. The skin engaging surface 10 engages the surfaceof the skin of a patient and would also limit the penetration depth ofthe needle tip 6 into a vial septum. The needle assembly 2 is secured tothe syringe 14 via the hub portion 9, which may be fixedly secured tothe syringe body 16, or the hub portion 9 may be secured by a Luer fitor equivalent attachment method. Alternatively, the needle assembly 2may be integrally formed on the syringe body 16.

The substances for use with the device and method include vaccines andcertain medicaments and drugs. Additionally, these substances can beused for diagnostic testing such as, for example, the Mantoux test todetermine immunity status against tuberculosis and immediatehypersensivity status of Type I allergic diseases. Also, the substanceintradermally delivered in accordance with aspects of the methods anddevices of the present invention is selected from the group consistingof drugs, vaccines and the like used in the prevention, diagnosis,alleviation, treatment, or cure of disease, with the drugs includingAlpha-1 anti-trypsin, Anti-Angiogenesis agents, Antisense, butorphanol,Calcitonin and analogs, Ceredase, COX-II inhibitors, dermatologicalagents, dihydroergotamine, Dopamine agonists and antagonists,Enkephalins and other opioid peptides, Epidermal growth factors,Erythropoietin and analogs, Follicle stimulating hormone, G-CSF,Glucagon, GM-CSF, granisetron, Growth hormone and analogs (includinggrowth hormone releasing hormone), Growth hormone antagonists, Hirudinand Hirudin analogs such as hirulog, IgE suppressors, Insulin,insulinotropin and analogs, Insulin-like growth factors, Interferons,Interleukins, Leutenizing hormone, Leutenizing hormone releasing hormoneand analogs, Low molecular weight heparin, M-CSF, metoclopramide,Midazolam, Monoclonal antibodies, Narcotic analgesics, nicotine,Non-steroid anti-inflammatory agents, Oligosaccharides, ondansetron,Parathyroid hormone and analogs, Parathyroid hormone antagonists,Prostaglandin antagonists, Prostaglandins, Recombinant solublereceptors, scopolamine, Serotonin agonists and antagonists, Sildenafil,Terbutaline, Thrombolytics, Tissue plasminogen activators, TNF-, andTNF-antagonist, the vaccines, with or without carriers/adjuvants,including prophylactics and therapeutic antigens (including but notlimited to subunit protein, peptide and polysaccharide, polysaccharideconjugates, toxoids, genetic based vaccines, live attenuated,reassortant, inactivated, whole cells, viral and bacterial vectors) inconnection with, addiction, arthritis, cholera, cocaine addiction,diphtheria, tetanus, HIB, Lyme disease, meningococcus, measles, mumps,rubella, varicella, yellow fever, Respiratory syncytial virus, tickborne japanese encephalitis, pneumococcus, streptococcus, typhoid,influenza, hepatitis, including hepatitis A, B, C and E, otitis media,rabies, polio, HIV, parainfluenza, rotavirus, Epstein Barr Virus, CMV,chlamydia, non-typeable haemophilus, moraxella catarrhalis, humanpapilloma virus, tuberculosis including BCG, gonorrhoea, asthma,atheroschlerosis malaria, E-coli, Alzheimers, H. Pylori, salmonella,diabetes, cancer, herpes simplex, human papilloma and the like othersubstances including all of the major therapeutics such as agents forthe common cold, Anti-addiction, anti-allergy, anti-emetics,anti-obesity, antiosteoporeteic, anti-infectives, analgesics,anesthetics, anorexics, anti arthritics, anti asthmatic agents,anticonvulsants, anti-depressants, antidiabetic agents, antihistamines,anti-inflammatory agents, antimigraine preparations, antimotion sicknesspreparations, antinauseants, antineoplastics, antiparkinsonism drugs,antipruritics, antipsychotics, antipyretics, anticholinergics,benzodiazepine antagonists, vasodilators, including general, coronary,peripheral and cerebral, bone stimulating agents, central nervous systemstimulants, hormones, hypnotics, immunosuppressives, muscle relaxants,parasympatholytics, parasympathomimetrics, prostaglandins, proteins,peptides, polypeptides and other macromolecules, psychostimulants,sedatives, sexual hypofunction and tranquilizers and major diagnosticssuch as tuberculin and other hypersensitivity agents.

In accordance with one embodiment of a medication container, thesesubstances are stored in medication vials with an open end, a rimsurrounding the open end and a reduced diameter neck portion adjacentthe rim. The vial is sealed, in some embodiments with an elastomericseptum, which includes a portion inserted into the neck of the vial anda planar rim portion which overlies the vial rim. The septum is normallysecured to the vial rim with an aluminum collar. In the case of aconventional syringe, the needle can be used to directly access a drugsubstance contained within the vial. In one embodiment, the minimumthickness of a standard vial septum is greater than 2 mm, nominally 3 mmand some are greater than 5 mm. Furthermore, at the edges of a vialstopper the thicknesses may exceed 8 mm. As described above, vialstoppers may also be coated with PTFE or other barrier coatings whichnot only add to the thickness, but add to the penetration resistance.

When the needle 4 of intradermal injection device 1 not is sufficientlylong to penetrate the septum to access the drug substance contained inthe vial, the use of a vial adapter 50 may be employed in order to useneedle 4 to fill the delivery device. Now referring to FIG. 4, vialadapter 50 includes protrusion 54 having a passage 52 adapted to receiveat least a portion of needle assembly 2. At the proximal end of passage52 is disposed septum 60. Septum 60 has a proximal face 61 and a distalface 62. At the distal end of vial adapter 50 is opening 58, adapted toreceive a portion of the medication vial. Preferably, opening 58 isadapted to receive the aluminum collar of the medication vial. Disposedin opening 58 is vial spike 70 having a point 76 which is adapted topierce the septum of the medication vial. Vial spike 70 is a generallyhollow structure formed by lumen 74 and further includes aperture 72disposed at the distal end of vial spike 70. The proximal end of vialspike 70 is fluid communication with distal face 62 of septum 60.

When the medication vial is inserted into opening 58, the distal end ofvial spike 70 including aperture 72 is penetrated through the septum ofthe medication vial. Vial Spike 70 protrudes a predetermined distancepreferably being in excess of about 5 mm from a portion of vial adapter50 such that aperture 72 is able to enter the interior of the medicationvial. Preferably, the protrusion of vial spike is in the range of about8 mm to about 15 mm, more preferably, is in the range of about 10 mm toabout 13 mm. The lumen 74 of vial spike 70 is in fluid communicationwith distal face 62 of septum 60. Furthermore, when the delivery device1 is inserted into passage 52, the needle tip 6 and lumen of needle 4 ofneedle assembly 2 is able to pass the distal face 62 of septum 60 by thecomplete penetration of septum 60. Preferably, the tip 6 and a portionof the lumen of needle 4 are now within a portion of lumen 74 of vialspike 70, thus allowing fluid communication. The thickness of septum 60is pre-selected such that the thickness of septum 60 is always less thanthe protrusion of needle 4 from limiter portion 11. Preferably, thethickness of septum 60 is in the range of about 0.01 mm to about 3 mm,more preferably, is in the range of about 0.25 mm to about 1 mm, morepreferably, is in the range of about 0.5 mm to about 1 mm. In thisembodiment the septum may be silicone or a suitable elastomer.Additionally, the septum may be pre-slit for easier penetration. In analternate embodiment, the septum is a film having a thickness of betweenabout 12 and about 4 mil. In a particular embodiment of film, the filmis a thermoform able polyethylene terephthalate (PET). In a particularembodiment of film, the film is a co-laminated or co-extruded filmincluding a layer of thermoform able polyethylene terephthalate (PET) onthe exterior thereof and an optional layer of heat-sealable polyethyleneon the interior thereof. In some of the embodiments, the septum 60 isheat sealed onto the vial adapter 50. In other embodiments septum 60 isretained mechanically within vial adapter 50. Thus, when vial adapter 50is used to access a medication vial, fluid communication between theinterior of the medication vial and the reservoir 18 is establishedthrough vial spike 70 and needle 4.

Opening 58 in vial adapter 50 may further include features to engage thevial while the vial is in opening 58. In one embodiment, vial adapter 50is slit with a plurality of slits 68 which form a plurality ofcantilevers 67. Cantilever 67 optionally includes lip 69 to help guidethe medication vial into opening 58. When the medication vial isinserted into opening 58, cantilevers 67 are deflectable radiallyoutward to allow medication vial to enter opening 58 with aninterference fit. Cantilevers 67 optionally include shoulder 66 so thata portion of the medication vial is positively (and releasably) lockedinto opening 58. In an alternate embodiment, medication vial ispermanently locked into opening 58 by selection of cantilever 67 andshoulder 66 dimensions which prevent the removal of the medication vialfrom opening 58.

In a preferred embodiment of the present invention, all components ofthe intradermal device 2 and the vial adapter are made from moldableplastic materials such as, for example, polymeric plastics such aspolyethylene, polypropylene, polycarbonate, and the like (except for theneedle cannula 4 which is preferably made from steel, and the septum 60which is preferably made from materials as described above or anelastomeric material). This construction allows for the vial adapter 50and vial spike 70 to be unitarily formed from a single moldable plastic.In an alternate embodiment, vial spike 70 is also constructed of steel.Furthermore, it may be possible to unitarily form septum 60 and vialadapter 50. These part reductions are especially helpful in ease ofassembly as well as reducing costs of manufacture.

The vial adapter 50 may be supplied as an add-on to conventional drugdelivery devices, i.e., glass or plastic syringes. In that case, thevial adapter 50 may be attached to a conventional medication vial andintradermal drug delivery device, such as a syringe at the point of use.Alternatively, the vial adapter 50 may be provided with an intradermalinjection device 1, thus comprising a system in accordance with certainembodiments of the present invention. Generally, the vial adapter 50 andintradermal device 1 will be provided with a protective packaging tomaintain the integrity of the unit and/or sterility thereof. The vialadapter 50 may further be provided with a protective cap to coveropening 58 and/or passage 52 prior to use thereof.

Now referring to FIGS. 6-9 which show an alternate embodiment havingaspects of the present invention. In this particular embodiment, needleassembly 2 is detachable from syringe body 16. The attachment of syringe14 to needle assembly 2 is by fitting 28. Fitting 28 provides for fluidcommutation between needle 4 and reservoir 18. Preferably, fitting 28 isa luer taper; however, in certain applications it may be desirable toconfigure fitting 28 with a proprietary-type connection with syringe 14.Disposed on needle assembly 2 is tang catch 21 which engages tang 51 onadapter 50. Tang catch 21 and tang 51 may be utilized on any embodimentdisclosed herein. Optionally, tang 51 is formed with a helical surfacesuch that engagement of tang 51 and tang catch 51 so that relativerotational movement about a longitudinal axis induces linear movement ofthe two components (adapter 50 and needle assembly 2). This may beuseful in applying additional forces which may be required to penetrateseptum 60 with needle 4. Tang 51 and tang catch 21 may be optionally beformed with a bayonet-type fit such that a partial relative rotationabout a longitudinal axis of the two components (adapter 50 and needleassembly 2) allows the two components to be removably attached.

In use, a health care professional administering the intradermalinjection will unwrap the protective packaging from the vial adapter 50(if provided as a separate component) or injection device 1. Ifnecessary, the injection device 1 can be filled with a diluent at thistime, using methods that are conventional and known in the art. Thehealth care professional will then manually insert the medication deviceinto the vial adapter 50 in preparation for aspiration of medicationinto reservoir 18. If supplied as separate components, the health careprofessional will then manually insert the intradermal delivery device 1into the vial adapter 50 (see, e.g., FIG. 5) in preparation foraspiration of medication. Alternatively, vial adapter 50 and deliverydevice 1 are pre-assembled. Optionally, at this point, a diluent isinjected in the medication vial. The healthcare professional thenaspirates the syringe with the medication from the medication vial fromreservoir 18. The health care professional will then manually remove themedication device 1 from vial adapter 50 in preparation foradministration of the intradermal injection. Administration will, in oneembodiment, involve pressing the skin engaging surface 10 of the limiter11 substantially perpendicular to a surface of the patient's skin. Thedrug substance will then be injected using the plunger 20 or otherdevice conventionally used to deliver a drug substance. The injectionwill continue for a period of time determined by one having skill in theart based on the particular substance being administered as well as thedosage volume. Upon completion of the injection, the health careprofessional withdraws the needle cannula 4 from the patient's skin anddisposes the used injection device 1 in a suitable container. Prior todisposal, the health care professional optionally activates theshielding portion of delivery device 1. A particular embodiment ofshielding device is disclosed further below.

As will now be understood, the intradermal delivery device havingaspects of the invention may include a needle enclosure means whichencloses or conceals the needle cannula tip following injection andwhich preferably cannot be retracted to prevent accidental needlecontact or reuse. In one embodiment shown in FIGS. 10-15, a shield maybe extended following injection and locked in place. In a secondembodiment shown in FIGS. 16-20, the assembly includes a re-extendableshield, which locks in the extended position, preventing contact withthe needle by use of shield clip for example, as is disclosed in U.S.Pat. Nos. 5,338,310; 5,385,555 and 4,631,057 each of the disclosure ofwhich are incorporated by reference herein in their entirety.Alternatively, the assembly may include a plunger lock via a plungerclip as disclosed, for example, in a copending US Publication2005/0027250A1 or U.S. Pat. Nos. 4,973,310 and 4,961,728 the disclosureof which is incorporated by reference. The plunger lock may alsoconfigured to lock the shield as is described below. The syringe barrelhas an elongate body portion, a proximal end, and a distal end, and aneedle at the distal end. A metal locking element is positioned in theshield between the barrel and the inside surface of the shield. Theoutside surface of the syringe barrel acts as a pathway for thelongitudinal motion of the locking element relative to the elongate bodyportion. The element includes a proximal portion and a distal portion,an optional proximally and outwardly facing locking barb, a distally andinwardly facing resisting edge and an inwardly facing driving edge atthe proximal portion of the element. The driving edge is adapted tointeract with the outer portion of the syringe barrel to move thelocking element along the bore of the shield as the barrel is advancedproximally along the barrel by force applied to the shield. Theresisting edge and the barb are adapted to prevent motion of the barrelwith respect to the shield after initial proximal motion of the shield.

Now referring to FIG. 10-13, which show an alternate embodiment havingaspects of the present invention. In this particular embodiment, needleassembly 2 is integral to syringe body 16 and includes threads 25 whichengages tang 51 on adapter 50. Threads 25 and tang 51 may be utilized onany embodiment disclosed herein. In this embodiment, threads 25 areformed with a helical surface such that engagement of tang 51 andthreads 25 is helical in nature and allows for positive connection ofthe two components (Device 1 and adapter 50).

Also shown in FIG. 10-13 is shield 30 which allows shielding the needleof the delivery device after use. Finger 32 of shield 30 having rails 41which cooperate with grooves 42 on needle assembly 2 to allow axialmovement of shield 30. Finger 32 also includes first detent 38 andsecond detent 36. Detents (36, 38) cooperate with lock 40 which is acantilevered beam on needle assembly 2 to retain shield 30 in desiredpositions. Shield 30 is normally retained in a proximal position byfirst detent 38, as shown in FIG. 15, which allows needle 4 to accessseptum 60 of adapter 50. After use, shield 30 is moved distally and lock40 engages second detent 36 to lock shield 30 in a distal position asshown in FIG. 13.

Also shown in FIG. 11 is plunger clip 26 which allows locking of plunger20 within syringe body 16 after a pre-prescribed number of strokes as isdescribed in co-pending US Publication 2005/0027250A1. Plunger clip 26cooperates with plunger detents 19 and the interior wall of syringe body16 to lock the plunger after use. The plunger clip 26, and detents 19are selected by using skill in the art to allow the following typicalstroke patterns of the plunger, wherein D=distal movement, andP=Proximal movement of the plunger: D; PD; DPD; PDPD; and PDPDPD. Theplunger clip may be used in any embodiment.

Now referring to FIG. 16-20, which show an alternate embodiment havingaspects of the present invention. In this particular embodiment, needleassembly 2 is assembled to syringe body 16 and preferably permanentlyassembled to syringe body 16, however a detachable assembly via afitting as described previously is possible with this embodiment. Device2 includes shield 30 which engages tang 51 on adapter 50. Shield 30 inposition shown in FIG. 17 cooperating with tang 51 and tang catch 21(disposed on shield 30 in this embodiment) allow for positive connectionof the two components (Device 1 and adapter 50). In this embodiment,tang catch 21 is shown shaped in a bayonet-type connection arrangementwith tang 51, however, other types of connections such as detented orthreaded could be used in this application, as described previously.

In this embodiment, septum 60 is disposed in a proximal portion ofprotrusion 54 of adapter 50. Furthermore, septum 60 is held in place byseptum retainer 64, which holds septum 60 onto adapter 50.Alternatively, septum 60 may be adhesively attached, or heat sealed ontoor integrally formed into adapter 50. One advantage of having aproximally located septum is the ability to wipe the septum prior topenetration to disinfect the septum prior to use. Alternatively, theseptum may be located distally on protrusion 54.

Shield 30 in this embodiment is a re-extendable shield, which locks inthe extended position after use, preventing contact with the needle byuse of shield clip 43. Preferably, shield 30 is first presented in theextended condition which allows easy connection of device 2 to adapter50. Shield 30 is slidably engaged in the syringe barrel by theengagement of the shield bore 31 with barrel stop 46 and barrel guide 17on syringe body 16. Forward stop 44 of shield 30 cooperates with barrelstop 46 to limit the distal travel of shield 30. Shield 30 is normallyretained in a distal position by Forward stop 44 and barrel stop 46along with shield clip 43, as shown in FIG. 17, which allows needle 4 toproximally located access septum 60 on protrusion 54 of adapter 50.Shield clip 43 is in a proximal position, which allows proximal movementof the shield with respect to the barrel. After filling, shield 30 ismoved distally to expose needle 4 for an injection into a patient asdescribed in detail above. The position of Shield 30 is now as is shownin FIG. 19. As shield 30 is moved distally, shield clip 43 is held inplace with respect to syringe body 16, thus is in second position withrespect to shield 30. After use, shield 30 is moved distally withrespect to syringe body 16 and shield clip 43 engages barrel detent 29to lock shield 30 in a distal position as shown in FIG. 20. The shieldclip 43, and barrel detents 29 are selected by using skill in the art toallow the following typical stroke patterns of the shield, whereinD=distal movement, and P=Proximal movement of the plunger: D; PD; andDPD.

The invention has been described in an illustrative manner, and it is tobe understood that the terminology which has been used is intended to bein the nature of words of description rather than of limitation.

Obviously, many modifications and variations of the present inventionare possible in light of the above teachings. It is, therefore, to beunderstood that within the scope of the appended claims, whereinreference numerals are merely for convenience and are not to be in anyway limiting, the invention may be practiced otherwise than asspecifically described.

1. A fluid transfer system for use in transferring a medical substancefrom a medication container having a septum with a pre-determinedthickness into a delivery device, comprising: a reservoir within saiddelivery device adapted for storing a medical substance; a needlecannula attached to said delivery device having a lumen in fluidcommunication to said reservoir and having a forward tip extending awayfrom said delivery device a pre-selected usable length, wherein saidusable length is less than a thickness of said septum of said container;an adapter body including: a container receiving portion said containerreceiving portion having a septum access needle, and a longitudinalprojection extending from said adapter body, said projection includingan adapter septum having a thickness, and a distal portion; wherein thethickness of said adapter septum is less than the usable length of saidneedle cannula and said distal portion is in fluid communication withsaid septum access needle lumen; wherein when said container is receivedin said container receiving portion and said delivery device needle ispenetrated through said adapter septum, fluid communication between saidsubstance in said container and said reservoir of said delivery deviceis established.
 2. A system as set forth in claim 1 further comprising ashield which is slidably disposed upon said delivery device having atleast a first position and a second position, said first positionexposing said forward tip of said needle cannula and said secondposition concealing said forward tip of said needle cannula.
 3. A systemas set forth in claim 2 wherein said shield includes at least one slotwherein said slot cooperates on a corresponding feature on said vialadapter protrusion wherein said cooperation allows removable attachmentof said delivery device to said vial adapter body
 4. A system as setforth in claim 3 wherein said vial adapter protrusion includes at leastone locking finger received by said slot in said shield.
 5. A system asset forth in claim 1 wherein said vial adapter protrusion includes atleast one protuberance received by a corresponding receptacle disposedon said medical device.
 6. A system as set forth in claim 1 wherein saidvial adapter protrusion includes at least one receptacle adapted toreceive at least one tang disposed on said medical device.
 7. A systemas set forth in claim 5 wherein said vial adapter protrusion at leastone protuberance is formed in a helical pattern and said at least onereceptacle adapted to receive at least one one tang disposed on saidmedical device.
 8. A system as set forth in claim 6 wherein said vialadapter protrusion receptacle is formed in a helical pattern.
 9. Asystem as set forth in claim 2 wherein said shield includes a catchengaging said at least one stop when said shield is in said secondposition thereby preventing said limiter from being moved into saidfirst position from said second position.
 10. A system as set forth inclaim 1 wherein said adapter septum is located at a distal portion ofsaid adapter projection.
 11. A system as set forth in claim 1 whereinsaid adapter septum is located at a proximal portion of said adapterprojection.
 12. A system as set forth in claim 11 further comprising ashield which is slidably disposed upon said delivery device having atleast a first position and a second position, said first positionconcealing said forward tip of said needle cannula and said secondposition exposing said forward tip of said needle cannula.
 13. A systemas set forth in claim 12 further comprising a locking clip which isslidably disposed between said shield and said delivery device having atleast a first position and a second position, said first positionallowing proximal movement of said shield with respect to said deliverydevice and said second position preventing proximal movement of saidshield with respect to said delivery device.
 14. A device as set forthin claim 13 wherein a first proximal movement of said shield withrespect to said delivery device into said second shield position engagessaid locking clip and moves said locking clip into said second positionof said locking clip, thereby preventing proximal movement of saidshield with respect to said delivery device.
 15. A method oftransferring a medical substance from a medication container having aseptum with a pre-determined thickness into a delivery device having areservoir in fluid communication to a needle cannula attached to saiddelivery device having a forward tip extending away from said deliverydevice a pre-selected usable length; wherein said usable length is lessthan said pre-determined thickness of said container septum comprisingthe steps of: providing an adapter including a septum access needlehaving a lumen, in fluid communication with a distal portion of anadapter septum having a thickness less than the usable length of saidneedle cannula; penetrating said medication container septum with saidseptum access needle, wherein when said container septum is penetratedwith said septum access needle fluid communication between said medicalsubstance and said lumen occurs; penetrating said adapter septum withsaid delivery device needle, wherein when said adapter septum ispenetrated with said delivery device needle, fluid communication betweensaid medical substance and said lumen occurs, whereby, fluidcommunication between said substance in said container and saidreservoir of said delivery device is established; and, aspirating saidmedical substance into said delivery device.
 16. The method of claim 15further comprising: shielding said delivery device needle with a needleshield, thereby concealing said forward tip of said needle cannula,wherein said shield is slidably engaged to said delivery device.
 17. Themethod of claim 16 further comprising: performing an injection with saiddelivery device, and locking said shield of said delivery device needlein a distal position after performing said injection step.
 18. Themethod of claim 17 further comprising: providing said delivery devicewith said shield in an initial distal position concealing said forwardtip of said needle cannula, wherein said forward tip is engageable tosaid adapter septum; and moving said shield to a proximal positionexposing said usable length of said needle cannula.
 19. A deliverydevice, comprising: a reservoir within said delivery device adapted forstoring a medical substance; a needle cannula attached to said deliverydevice having a lumen in fluid communication to said reservoir andhaving a forward tip extending away from said delivery device apre-selected usable length; a shield which is slidably disposed uponsaid delivery device having at least a first position and a secondposition, said first position concealing said forward tip of said needlecannula and said second position exposing said forward tip of saidneedle cannula; and a locking clip which is slidably disposed betweensaid shield and said delivery device having at least a first positionand a second position, said first position allowing proximal movement ofsaid shield with respect to said delivery device and said secondposition preventing proximal movement of said shield with respect tosaid delivery device wherein a first proximal movement of said shieldwith respect to said delivery device into said second shield positionengages said locking clip and moves said locking clip into said secondposition of said locking clip, thereby preventing subsequent proximalmovement of said shield with respect to said delivery device.
 20. Adelivery device as set forth in claim 19 wherein said shield includes atleast one slot wherein said slot cooperates on a corresponding featureon a medication vial protrusion wherein said cooperation allowsremovable attachment of said delivery device to said vial.